首个吡格列酮仿制药上市但附带心衰警告

美国食品药品管理局(FDA)8月17日宣布，已批准2型糖尿病口服治疗药物吡格列酮的首个仿制药上市。

吡格列酮是一种噻唑烷二酮类药物(TZD)，于1999年通过审批，用于在饮食和运动治疗的基础上改善2型糖尿病患者的血糖控制，由武田制药公司美国分部销售，商品名为艾可拓。用法为每日1次，不受进食时间影响。

本次获准的仿制药是由Mylan制药公司生产的，通过审批的为15 mg、30 mg和45 mg片剂，艾可拓也有这3种剂量的剂型。FDA在声明中指出，与品牌药一样，患者在获得吡格列酮仿制药处方的同时将收到一份用药指南，后者提供了关于药物使用和安全性的信息。

吡格列酮的药品标签中含有一项加框警告，指出接受TZD(包括吡格列酮)治疗可能引起或加重心力衰竭，对于接受吡格列酮治疗的患者应严密监测心力衰竭；这种药物禁用于纽约心脏病协会(NYHA)Ⅲ级或Ⅳ级心力衰竭患者。这个加框警告是在2007年被列入TZD药品标签的。标签中还指出，吡格列酮治疗1年以上可能增加膀胱癌的风险，这项警告是在2011年被列入的。

目前有学者正在研究将吡格列酮作为一种阿尔茨海默病治疗药物的可能性。

在美国市场上的另一种TZD为罗格列酮(文迪雅)，因为相关心血管风险而应用高度受限。文迪雅的药品标签中还包含关于治疗相关的心肌梗死风险增高的声明。

对于与吡格列酮相关的严重不良事件，应报告至FDA的MedWatch不良事件报告系统，电话为800-332-1088，或点击进入。

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By: ELIZABETH MECHCATIE, Cardiology News Digital Network

The first generic formulation of the orally administered type 2 diabetes drug pioglitazone has been approved by the Food and Drug Administration, the agency announced on Aug. 17.

Pioglitazone, a thiazolidinedione (TZD), was approved in 1999, as an adjunct to diet and exercise, to improve glycemic control in adults with type 2 diabetes mellitus, and has been marketed as Actos by Takeda Pharmaceuticals America. It is taken once daily without regard to meals.

The generic formulation is manufactured by Mylan Pharmaceuticals. Approved are 15-mg, 30-mg, and 45-mg tablets, the three Actos doses available. As with the brand-name version, patients will receive a Medication Guide with all filled generic pioglitazone prescriptions, which provides information about the drug’s use and safety, according to the FDA statement.

The pioglitazone label has a boxed warning stating that treatment with TZDs, including pioglitazone, can cause or exacerbate heart failure, and that patients on treatment with pioglitazone should be monitored closely for heart failure; it is contraindicated in patients with New York Heart Association (NYHA) III or IV heart failure. The label also includes the statement that the risk of bladder cancer may be increased after 1 year of treatment with pioglitazone, which was added to the drug’s label in 2011. This boxed warning was added to the TZD labels in 2007.

Pioglitazone is also being studied as a treatment for Alzheimer’s disease.

The other TZD on the U.S. market is rosiglitazone (Avandia), but its use is highly restricted because of its associated cardiovascular risks. The Avandia label also includes a statement on the increased risk of myocardial infarction associated with treatment.

Serious adverse events associated with pioglitazone should be reported to FDA’s MedWatch adverse event reporting program at 800-332-1088 or here.